title: Are IgM-enriched immunoglobulins an effective adjuvant in septic VLBW infants?
abstract: OBJECTIVE
  To investigate the effectiveness of IgM-enriched immunoglobulins (IgM-eIVIG) in reducing short-term mortality of neonates with proven late-onset sepsis.
  
  
  METHODS
  All VLBW infants from January 2008 to December 2012 with positive blood culture beyond 72 hours of life were enrolled in a retrospective cohort study. Newborns born after June 2010 were treated with IgM-eIVIG, 250 mg/kg/day iv for three days in addition to standard antibiotic regimen and compared to an historical cohort born before June 2010, receiving antimicrobial regimen alone. Short-term mortality (i.e. death within 7 and 21 days from treatment) was the primary outcome. Secondary outcomes were: total mortality, intraventricular hemorrhage, necrotizing enterocolitis, periventricular leukomalacia, bronchopulmonary dysplasia at discharge.
  
  
  RESULTS
  79 neonates (40 cases) were enrolled. No difference in birth weight, gestational age or SNAP II score (disease severity score) were found. Significantly reduced short-term mortality was found in treated infants (22% vs 46%; p = 0.005) considering all microbial aetiologies and the subgroup affected by Candida spp. Secondary outcomes were not different between groups.
  
  
  CONCLUSIONS
  This hypothesis-generator study shows that IgM-eIVIG is an effective adjuvant therapy in VLBW infants with proven sepsis. Randomized controlled trials are warranted to confirm this pilot observation.
authors.affiliation: Neonatal Intensive Care Unit, Department of Pediatrics, Università degli Studi di Napoli Federico II, Via S, Pansini 5, 80131 Naples, Italy. letizia.capasso@gmail.com.
authors.forename: Letizia
authors.initials: L
authors.lastname: Capasso
authors.forename: Angela Carla
authors.initials: AC
authors.lastname: Borrelli
authors.forename: Claudia
authors.initials: C
authors.lastname: Parrella
authors.forename: Silvia
authors.initials: S
authors.lastname: Lama
authors.forename: Teresa
authors.initials: T
authors.lastname: Ferrara
authors.forename: Clara
authors.initials: C
authors.lastname: Coppola
authors.forename: Maria Rosaria
authors.initials: MR
authors.lastname: Catania
authors.forename: Vita Dora
authors.initials: VD
authors.lastname: Iula
authors.forename: Francesco
authors.initials: F
authors.lastname: Raimondi
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D000704:Analysis of Variance; D015331:Cohort Studies; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D007070:Immunoglobulin A / Q000627:therapeutic use; D007075:Immunoglobulin M / Q000276:immunology / Q000627:therapeutic use*; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight; D007262:Infusions, Intravenous; D007363:Intensive Care Units, Neonatal; D007558:Italy; D007902:Length of Stay; D008297:Male; D016017:Odds Ratio; D012189:Retrospective Studies; D018570:Risk Assessment; D018805:Sepsis / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality*; D012720:Severity of Illness Index; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D004338:Drug Combinations; D007070:Immunoglobulin A; D007075:Immunoglobulin M; D016756:Immunoglobulins, Intravenous; C060166:pentaglobulin